Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of study eyes with elimination of collarettes
研究概览
简要总结
This is a randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center study designed to evaluate the safety and efficacy of GLK-321 in patients with Demodex blepharitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs of Demodex blepharitis in at least one eye
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye
排除标准
- •Presence of eczema or dermatitis in the ocular region of either eye
- •Use of lid hygiene products within 14 days of Screening
- •Active ocular infection or inflammation, other than blepharitis, in either eye at Screening
- •Women who are pregnant, planning a pregnancy, or nursing
- •Have used an investigational drug or device within 30 days prior to Screening or concurrently enrolled in another investigational drug or device trial
研究组 & 干预措施
Placebo BID
Placebo administered twice daily (BID) to both eyes
干预措施: Placebo BID (Drug)
GLK-321 low dose BID
Low dose of GLK-321 administered twice daily (BID) to both eyes
干预措施: GLK-321 low dose BID (Drug)
GLK-321 mid dose BID
Mid dose of GLK-321 administered twice daily (BID) to both eyes
干预措施: GLK-321 mid dose BID (Drug)
GLK-321 high dose BID
High dose of GLK-321 administered twice daily (BID) to both eyes
干预措施: GLK-321 high dose BID (Drug)
GLK-321 high dose QD
High dose of GLK-321 administered once daily (QD) to both eyes
干预措施: GLK-321 high dose QD (Drug)
结局指标
主要结局
Percentage of study eyes with elimination of collarettes
时间窗: 6 weeks
Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment
次要结局
未报告次要终点